KR20220038390A - Methods and apparatuses for aspects of a dose detection system - Google Patents

Abstract

The techniques described herein detect the color of a portion of a medicament delivery device to determine the medicament contained in the medicament delivery device using, for example, a light sensor and a set of LEDs for different temperature conditions, For example, a dose sensing module may be configured to monitor battery life of a battery of the dose sensing module using, for example, current/voltage detection for different temperature conditions, eg, medicament delivery in conjunction with, for example, dose detection sensors. At least one computerized method and apparatus for determining whether to attach to a device. At least some of the information obtained from these techniques may be communicated to a paired remote electronic device, such as a user's smartphone.

Description

Methods and apparatuses for aspects of a dose detection system

The present disclosure relates to techniques for an electronic dose detection system for a medicine delivery device, and in particular, to detect a connection to the medicament delivery device, and to determine the type of the medicament delivery device. techniques for determining and monitoring battery life.

Patients suffering from various diseases have to frequently self-inject medicines. In order to enable a person to conveniently and accurately self-administer a drug, various devices, popularly known as pen injectors or injection pens, have been developed. Generally, such pens include a cartridge that includes a piston and contains a multi-dose quantity of liquid medicament. The drive member may be moved forward to advance the piston within the cartridge to dispense, typically through a needle, a containment medicament from an outlet located at the distal cartridge end. In disposable or prefilled pens, after the pen is used and consumes the supply of medicament in the cartridge, the user discards the entire pen and begins using a new replacement pen. In reusable pens, after the pen is used and consumes the supply of medicament in the cartridge, the pen is disassembled so that the spent cartridge can be replaced with a new cartridge, and then the pen is reassembled for its subsequent use.

Many pen injectors and other medicament delivery devices utilize mechanical systems in which the members are rotated and/or translated relative to each other in a manner proportional to the dose delivered by motion of the device. Accordingly, the art has sought to provide reliable systems that accurately measure the relative movement of members of a medicament delivery device to assess delivered administration. Such systems may include a sensor that detects relative movement of a sensed component secured to a first member of the medicament delivery device and secured to a second member of the device.

Dosing of an appropriate amount of medicament requires that the administration delivered by the medicament delivery device be accurate. Many pen injectors and other medicament delivery devices do not include functionality for automatically detecting and recording the amount of medicament delivered by the device during an injection event. In the absence of an automated system, the patient must manually keep track of the amount and time of each infusion. Accordingly, there is a need for a device operable to automatically detect administration delivered by the medicament delivery device during an infusion event. Also, such a dose detection device needs to be removable and reusable with multiple delivery devices. In other embodiments, such a dose detection device may need to be integrated with the delivery device.

It is also important to deliver the correct medication. The patient may have to choose between different medications, or different forms of a given medication, depending on circumstances. If a mistake is made as to which medicament is in the medicament delivery device, it will not be properly administered to the patient, and administration dosing records will be inaccurate. If a dose detection device that automatically identifies the type of medicament received by the medicament delivery device is used, the likelihood of this happening is significantly reduced.

The present disclosure relates to techniques for a dose sensing module that can be removably attached to a medicament delivery device. Techniques may include determining whether a dose sensing module is attached to a medicament delivery device. These techniques can detect, process, and/or only events detected when, for example, the dose sensing module is attached to the medicament delivery device (as opposed to accidental activation when the dose sensing module is not coupled to the medicament delivery device). or report, and may be used to determine when the dose sensing module changes for a new medicament delivery device. Techniques may also include detecting the color of a portion of the medicament delivery device to determine a medicament contained in the medicament delivery device. Such techniques can ensure, for example, that the patient is administering the correct medication to avoid mistakes about what medication is in the medication delivery device. The techniques may further include monitoring a battery life of a battery of the dose sensing module. These technologies allow the user or patient to extend battery life in a way that, for example, allows the user or patient to plan in advance appropriately, and in a way that allows the patient to know much ahead of time when the battery is going to run out, in a reliable way. can be monitored.

Additional embodiments of the present disclosure, as well as features and advantages thereof, will become more apparent upon reference to the description of this specification taken in conjunction with the accompanying drawings. Components in the drawings are not necessarily to scale. Also, in the drawings, like reference numerals indicate corresponding parts throughout the different drawings.
1A is a diagram of an example system in accordance with some embodiments.
1B shows a block diagram of a controller and its components in accordance with some embodiments.
1C is a diagram of an example system in accordance with some embodiments.
2 is a flow diagram of an example computerized method for determining a color associated with an object in accordance with some embodiments.
3 is a flow diagram of an exemplary computerized method for generating calibration parameters in accordance with some embodiments.
4 is a flow diagram of an example computerized method for determining a battery indication in accordance with some embodiments.
5 is a perspective view of an exemplary medicament delivery device that may be operated with a dose detection system of the present disclosure.
6 is a cross-sectional perspective view of the exemplary medicament delivery device of FIG. 5 .
7 is a perspective view of a proximal portion of the exemplary medicament delivery device of FIG. 5 .
8 is a partially exploded perspective view of a proximal portion of the exemplary medicament delivery device of FIG. 5, in conjunction with a dose detection system of the present disclosure;
9 is a side schematic view in partial cross-section of a dose detection system module according to another exemplary embodiment attached to a proximal portion of a medicament delivery device;
10A and 10B and 11A and 11B show still other exemplary embodiments of dose detection systems using magnetic sensing.
12 is an axial view of another exemplary embodiment of a dose delivery detection system utilizing magnetic sensing.
13 illustrates an example computerized method for determining whether an apparatus is removably coupled to a medicament injection device in accordance with some embodiments.

For purposes of helping to understand the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe these embodiments. Nevertheless, it will be understood that no limitation on the scope of the invention is intended thereby.

The present disclosure relates to sensing systems for medicament delivery devices. In one aspect, the sensing system is for determining whether the sensing system is mounted to a medicament delivery device. The inventors have discovered and recognized that it may be desirable to allow a dose sensing system to be removably coupled to a medicament delivery device. However, the inventors limit the variety of hardware, firmware and/or software desired to be included in such dose sensing systems to include only those components that keep the dose sensing system small and user-friendly and less likely to fail due to repeated use. Given the desire to, discover and recognize that it can also be difficult to incorporate additional components (eg switches, latches, etc.) to detect when the dose sensing system is coupled to the medicament delivery device. did The techniques described herein provide for utilizing existing components of a dose sensing device to determine whether the dose sensing device is coupled to a medicament delivery device. For example, a dose sensing device may include sensors (such as Hall effect sensors) and associated hardware and/or software to determine the size of a dose administered by the medicament delivery device. The techniques may also utilize such hardware and/or software used to perform dose detection to determine whether a dose sensing system is coupled to a medicament delivery device.

In a second aspect, the sensing system is for determining the type of medicament contained within the medicament delivery device. As described herein, the inventors have discovered and recognized that issues may arise from the inability to determine a medicament in a medicament delivery device. For example, an incorrect medication may be administered to a patient, which may result in inappropriate patient dosing, inaccurate dosing records, and the like. The techniques described herein provide for sensing the color of a component of a medicament being administered by a medicament delivery device, wherein the color indicates the type of medicament. In some embodiments, the techniques utilize one or more light emitting diodes and light sensors to illuminate the applicable colored component and process the illumination data to match the color to a stored set of colors and associated medications.

In a third aspect, the sensing system is for monitoring a battery life of the sensing system. The inventors have discovered and recognized that determining the remaining battery life of a battery is complicated by various factors such as temperature, relaxation time, duration of use, load variation, battery brand, battery variability and other parameters. The inventors have developed techniques for monitoring a battery based on a dose sensing device architecture in a way that incorporates other relevant data such as temperature. Techniques may provide battery life estimates that adjust the measurement process in a way that avoids errors that may otherwise be introduced by existing battery measurement techniques.

By way of example, the medicament delivery device is described in the form of a pen injector. However, the medicament delivery device may be any device used to establish and deliver the administration of a medicament, such as an infusion pump, bolus injector or automatic injector device. The medicament may be of any type that can be delivered by such a medicament delivery device.

While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are merely examples and are not the only possible embodiments and implementations. Moreover, the advantages described above are not necessarily the only advantages, and not all advantages described are necessarily expected to be achieved in all embodiments.

Devices described herein, such as device 10 , may further contain a medicament in, for example, a reservoir or cartridge 20 . In another embodiment, the system may include device 10 and one or more devices including a medicament. The term "medication" refers to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, dula glue. GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide ( GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that can be delivered by the aforementioned device. one or more therapeutic agents, including but not limited to. A medicament as used in the device may be formulated with one or more excipients. The device is generally operated in the manner described above by a patient, caregiver or health care professional to deliver a medicament to a person.

1A is a diagram of an example system 120 in accordance with some embodiments. System 101 includes a sensing system 103 that communicates with a remote computing device 104 via a communication unit 106 (eg, via a wired and/or wireless connection). The communication unit 106 may be, for example, a WiFi transceiver, a Bluetooth transceiver, an RFID transceiver, a USB transceiver, a near-field communication (NFC) transceiver, a combination chip, or the like.

As further described herein, the sensing system 103 may be configured to determine illumination data indicative of the color of the object. The sensing system 103 includes an optical sensor 110 and a processing unit 108 (eg, MCU) in communication with a control unit 112 . Optical sensor 110 is in optical communication with object 116 (eg, part of a medicament delivery device). In some embodiments, light sensor 110 is, for example, an Ambient Light Sensor (ALS) operating in a reflective mode. The LED driver 112 is in communication with a set of light emitting diodes (LEDs) 114A, 114B and 114C (collectively the LEDs 114 ) in optical communication with the object 116 . For example, the LEDs 114 may include a red LED, a blue LED, and/or a green LED. The light sensor 110 , the LEDs 114 , or both are optionally in optical communication with the object 116 via an optional light guide 118 . The light guide 118 may be a transparent light guide, such as a Makrolon 2458 LightGuide. In some embodiments, the color sensor consists of individual LEDs, single package RGB LEDs, or a combination thereof.

1B illustrates a detailed example of an electronic assembly of a sensing module, referred to as 1400, that may be included in any of the modules described herein. The MCU is programmed to achieve the electronic features of the module. The MCU is configured to detect a connection to the medicament delivery device, determine the type of medicament delivery device, obtain data used to determine the administration delivered by the medicament delivery device, and battery life of the medicament delivery device. control logic operative to perform the operations described herein, including monitoring the The MCU may be operable to obtain data by detecting and/or determining an amount of rotation of a rotation sensor secured to the flange, which may be rotated by sensing elements of a measurement sensor, such as, for example, Hall effect sensors of the system. It is determined by detecting the magnetic field of the sensor.

Assembly 1400 includes dose sensors 1402A-E, memory 1408, identification sensor 1404, counter 1414, light driver 1411 and light indicators 1412, a power-supply module (power). MCU, which may be operatively coupled to one or more of an -on module 1406 , a communication module 1410 , a display driver/display 1416 , a power source 1418 , and a presence module 1420 . includes Assembly 1400 may include any number of dose sensors, such as, for example, five magnetic sensors 1402A-E (shown) or six sensors. Dosing sensors are used to determine total rotational units of components within the medicament delivery device that can be used to determine a administered dose (eg, as discussed further herein with respect to FIGS. 5-12 ). may be used, and may also be used to detect a connection to a medicament delivery device. The MCU may be configured via the presence module 1420, shown as arbitrary in this embodiment by dashed lines, to determine whether the module is coupled to a button on the device via triggering of the presence switch system. The MCU is configured to determine a color of the dose button via the identification sensor 1404 and, in some examples, associate the determined color data onboard or offboard with an external device (eg, remote computing device 104 ); , the color corresponds to a particular agent (eg, using LEDs 114 , as discussed further herein). The MCU is configured to determine the triggering of the wake-up switch to power the electronic assembly for use shown as the power-supply module 1406 . In one example, the total rotation may be communicated to an external device including a memory having a database, lookup table, or other data stored in the memory to correlate the total rotation units with the amount of medicament delivered for a given medicament identified. In another example, MCUs may be configured to determine the amount of medicament delivered. The MCU may be operable to store the detected dose in local memory 1408 (eg, internal flash memory or onboard EEPROM). MCU can, for example, rotate units, medicament identification data (such as color), timestamp, time since last dose, battery charge status, module identification number, module attach or detach time, inactivity time, and/or other errors. Bluetooth low energy signals representing device data such as (eg, dose detection and/or transmission errors, drug identification detection and/or transmission errors) (any one or any combination thereof) ) (BLE) or other suitable short-range or long-range wireless communication protocol module 1410, such as, for example, Near Field Communication (NFC), WiFi or a cellular network, wirelessly to a paired remote electronic device such as a user's smartphone further operative to transmit. Illustratively, the BLE control logic and the MCU are integrated in the same circuit. In one example, any of the modules described herein can include a display module 1420 , shown as optional by dashed lines in this embodiment, for displaying information to a user. Such a display, which may be LEDs, LCD, or other digital or analog displays, may be integrated with the proximal portion finger pad. The MCU is configured to receive and process the sensed data and display information such as, for example, dosing settings, dispensed doses, infusion status, infusion completion, date and/or time, or time until next infusion on the display. It contains an operative display driver software module and control logic. In another example, the MCU is used to communicate whether data was successfully transmitted to the patient by on-off and sequences of different colors, whether the battery charge is high or low, or other clinical communications, e.g. , an LED driver 1411 coupled to one or more LEDs 1412 such as RGB LEDs, orange LEDs, and green LEDs. The counter 1414 is shown as a real time clock (RTC) that is electronically coupled to the MCU to keep track of a time such as, for example, dosing time. Counter 1414 may also be a time counter that tracks seconds from zero based on energization. The time or count value may be communicated to an external device.

In some embodiments, as discussed further in connection with FIGS. 8-12 , the sensing system 103 is configured to be coupled to a medicament delivery device. In some embodiments, the object 116 is a portion of the medicament delivery device (eg, a button, label, color of an outer compartment) that can be used to identify an aspect of the medicament delivery device based on the color of the object 116 . etc) is. For example, the color of the object 116 may indicate the type of medicament of the medicament delivery device.

1C is a diagram of an example system 130 in accordance with some embodiments. System 130 includes aspects of a dose detection system that includes a sensing system 132 that communicates with a remote computing device 134 via a communication unit 136 (eg, via a wired and/or wireless connection). do. As further described herein, the sensing system 132 may be configured to determine a battery indicator indicative of the remaining life of the battery 138 . The device 132 includes a processing unit 140 in communication with a communication unit 136 , a battery 138 and a temperature sensing unit 142 .

Exemplary aspects of the dose detection system described in connection with FIGS. 1A-1C are shown for illustrative purposes to highlight various aspects of the dose detection systems. 1A-1C may be combined into a single device, such as the dose delivery detection system 80 described with respect to FIGS. 8-12 , e.g., various It can be implemented using example configurations.

1A , in some embodiments, the sensing system 103 is configured to determine a color of an object (eg, a button on a pen medicament delivery device). In some embodiments, the sensing system determines the object color by switching on the LEDs 114 in sequence and reading back the beams reflected through the broad spectrum ambient light sensor 110 . The sensing system 103 may generate various values, such as three values, for each of the three LEDs 114 . The sensing system 103 may process the generated values to generate a final color value for matching. The sensing system 103 may check the final color value against a predefined set of colors to determine whether there is a match.

2 is a flow diagram of an example computerized method 200 for determining a color associated with an object in accordance with some embodiments. A processor, such as the processing unit 108 of the sensing system 103 , may execute computer readable instructions causing the processor to perform the method 200 . In step 202, the sensing system obtains illumination data of an object illuminated by the set of LEDs. The sensing system may optionally process the lighting data in steps 204 and/or 206 to generate processed lighting data. At 204 , the sensing system optionally adjusts the lighting data based on the temperature. In step 206, the sensing system optionally normalizes the lighting data. At step 208 , the sensing system causes the light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs. At step 208 , the sensing system transmits the processed lighting data to the remote device (eg, via a communication module in communication with a processor of the apparatus). At step 210 , the remote device determines whether the lighting metrics match the stored set of colors. If the remote device determines a match, at step 212 the remote device outputs the matched color (eg, to a program, display, etc.). If the remote device has not determined a match, at step 214 the remote device outputs that no color match was found (eg, by returning an error code, no match code, etc.).

Referring to step 202 , the sensing system is configured with first illumination data when the object is not illuminated by the set of LEDs, second illumination data when the object is illuminated by each LED of the set of LEDs, or both. It can be configured to capture different For example, the device may be configured to capture lighting data for an object when the object is illuminated only by ambient light when the LEDs are not turned on. In some embodiments, the sensing system may include an exposure time to capture dark lighting data.

As another example, if the set of LEDs includes different color LEDs, the device may be configured to capture lighting data of the object as the object is illuminated by each LED. For example, as shown in FIG. 1A , in some embodiments, the device includes a red LED 114A, a blue LED 114B, and a green LED 114C. The device is configured such that the light sensor 110 has lighting data when the object is illuminated by a red LED 114A (rather than other LEDs), lighting data when the object is illuminated by a blue LED 114B, and when the object is green may be configured to adjust the light sensor 110 and the LED driver 112 to adjust the capture of illumination data and illumination of the LEDs 114 to capture illumination data when illuminated by the LED 114C. In some embodiments, the sensing system may be configured to use an exposure time to capture illumination data that may be the same for each LED and/or may be different for one or more LEDs.

Referring to step 204 , lighting data may be adjusted based on temperature. In some embodiments, the temperature of the ambient air, the sensing system, and/or the medicament delivery device is taken. In some embodiments, the sensing system may capture a plurality of temperature measurements and average the values to determine an averaged temperature for use in adjusting the lighting data. In some embodiments, the sensing system may adjust each illumination data value (X) using Equation (1).

here,

rgbTempX is an adjusted lighting data value determined for each color, such as a red value, a green value, and a blue value, depending on the color for which Equation 1 is being calculated,

rgbX is each original lighting data value, such as red value, green value and blue value,

·TempCoefficientX is the temperature coefficient for each value, allowing multiple temperature measurements to be tracked using one coefficient (for example, because there may be performance drift in different temperature measurements).

CalTemp is the temperature measured during calibration of the sensing system, which can be used to account for temperature changes (eg, relative to non-calibration measurements);

Temp is the measured (eg averaged) temperature.

Referring to step 206 , the sensing system may normalize the (temperature adjusted) lighting data based on the dark lighting data captured without illumination of the LEDs. In some embodiments, the sensing system may normalize the lighting data based on one or more lighting measurements determined during calibration. For example, Equation 2 may be used to normalize each illumination data value (X).

here,

bNormX is a normalized illumination value equal to a red, green or blue normalized value depending on the color for which Equation 2 is being calculated (in percentage, multiplied by 100),

whiteX represents illumination values, such as red, green and blue values obtained during the calibration phase when using a white target object (described further in connection with FIG. 3 );

blackX represents illumination values, such as red, green and blue values obtained during the calibration phase when using a black target object (described further in connection with FIG. 3 );

calDark is the dark illumination value (with LEDs off) determined during the calibration phase (described further with respect to FIG. 3 );

• darkValue is the dark lighting value determined during step 202 .

Referring to step 210 , the remote device may be configured to determine brightness A B (LABc) values. The system may determine the LABc values based on any of the lighting values whether the lighting data is raw lighting data, or lighting data that is temperature adjusted and/or normalized lighting data. For purposes of illustration, the following examples refer to normalized lighting data for simplicity. A value may be calculated according to the normalized illumination values. For example, depending on whether rgbNormRed determined using Equation 2 is greater than rgbNormGreen, then either Equation 3 or 4 is used to determine the A value.

A B value may also be calculated according to the normalized illumination values. For example, depending on whether rgbNormBlue determined using Equation 2 is greater than rgbNormGreen, then either Equation 5 or 6 is used to determine the B value. In Equation 3-6, Kn is used for RGB to LABc conversion so that the A and B values are in the range of -100 to 100 and L is in the range of 0 to 100 (eg, 20, 21.5, 23, etc.) is the coefficient to be

The L value can be calculated using Equation (7).

In some embodiments, the remote device can include a table of metrics used to determine whether the lighting data meets a color. The remote device may include a set of colors (eg, gray, blue, dark blue, red, and/or other colors), where each color has an associated set of data. The data associated with each color may include average data and/or sigma variation data determined during calibration and/or design of the system. In some embodiments, each color may include an average for each of the A, B, and L values, and a sigma change value for each of the A, B and L values. The remote device may determine the sigma distance for each color in the set of stored colors and the lighting data. For example, equation (8) can be used to determine the sigma distance for each color in a set of colors.

here,

SigmaDistanceX is the sigma distance for the color under consideration (X) from the set of colors,

・About real-time measurement,

○ L is calculated using Equation 7,

○ A is calculated using either Equation 3 or 4,

○ B is calculated using either Equation 5 or 6,

・About the color (X) under consideration,

○ μLX is the average of L values for color (X),

○ σLX is the sigma change of the L value for the color (X),

○ μAX is the average of A values for color (X),

○ σAX is the sigma change of A value for color (X),

○ μBX is the average of B values for color (X),

○ σBX is the sigma change of B value for color (X).

The remote device can use the sigma distances to determine whether the lighting data matches a color in the set of colors. For example, the remote device may select the minimum of the sigma distance values (Min1) as the most likely matching color. As discussed further herein, the second smallest value (Min2) may be used for the color matching check.

The sensing system and/or remote device may be configured to perform one or more checks on the lighting data. For example, under LED lighting, the dark lighting data can be checked to determine whether subsequent measurements are being interfered with by ambient light. As another example, the lighting data obtained for the LEDs can be checked to ensure that the lighting data is within an expected threshold between the lowest black value and the highest white value. As a further example, these values may be checked to determine whether the LABc values are within acceptable ranges (eg, -100 to 100 for A or B, 0 to 100 for L). As another example, a color matching check may be performed to ensure that Min1 and/or Min2 are within acceptable values. For example, Min1 may be checked to ensure that Min1 is less than the maximum sigma distance for an expected color match, and/or the ratio of Min2/Min1 may be compared to the minimum ratio between the two minimums for an acceptable match. can

During calibration, the sensing device can take various measurements that can be used to calibrate real-time measurements of the object. Calibration measurements may include temperature and various light measurements, such as measurements using a white target, a black target, and dark lighting in which any LEDs are not turned on. 3 is a flow diagram of an example computerized method 300 for generating calibration parameters in accordance with some embodiments. In step 302, the device measures a temperature. At step 304 , the device captures lighting data for a white target object (eg, a white object). At step 306 , the device captures illumination data for a black target (eg, a black object). At step 308 , the device captures lighting data for dark light with no LEDs turned on. In step 310, the device generates a set of calibration parameters. The calibration parameters are the dark measurement and/or exposure time (or maximum/minimum exposure times) to be used for each LED (eg red, green and blue LEDs), each for each white and/or black object. counts read during calibration for the LED, temperature, temperature margin, and/or other calibration parameters.

As described herein, a dose sensing system includes a sensing module having various components including a processor/MCU, sensors, LEDs, among other components. In some embodiments, the sensing module may be powered by a battery. Referring to FIG. 1C , for example, the sensing system 132 includes a battery 138 that powers the dose sensing system including the example components shown in FIG. 1C . The techniques described herein may be used to monitor battery life of a dose sensing system. Battery life may be monitored to provide the user with information such as a battery status indicator that tracks the life of the battery, alerts related to the battery (eg, alerts the user to low battery life, when to change the battery, etc.), and the like. For example, the dose sensing system, whether via a sensing module or a remote computing device, can be configured to provide a user with sufficient time to replace the battery when the battery is depleted (eg, 1 or 2 weeks before the end of its life) can be alerted to the user.

We found that estimating battery life, such as by using battery voltage measurements, depends on battery behavior temperature, relaxation time per measurement, infusion duration of an attached drug delivery device, load change, battery brand, battery variability, and other parameters. found and recognized that it can be complicated by the fact that it can depend on a number of variables such as To address these issues, which are often not controllable by the device provider, we provide a sufficient margin for battery life to compensate for potential error(s) and variability recognized by the inventors that may otherwise occur during battery measurement. We developed technologies to monitor the battery based on the device architecture in a way that provides

4 is a flow diagram of an example computerized method 400 for determining a battery indication in accordance with some embodiments. A processor, such as processing unit 140 of apparatus 132 of FIG. 1B , may be configured to execute computer readable instructions causing the processor to perform method 400 . In step 402, the device obtains a set of voltage measurements of the battery. At step 404 , the device obtains a temperature measurement (eg, via a temperature sensing module). At step 406 , the device determines a set of temperature-adjusted battery indications based on the temperature measurement. At step 408 , the device determines a battery indicator indicative of the remaining life of the battery based on the set of temperature-adjusted battery indications and voltage measurements.

Referring to step 402 , the device (eg, MCU) may obtain various voltage measurements when the battery is under different loads and/or when the device is in different operating states. In some embodiments, the device (a) a startup battery voltage when the device is powered on, (b) a high current battery voltage when the processor is running at full speed, (c) the processor is running in a low power mode When it is on, it acquires a low current battery voltage, or some combination thereof. The starting battery voltage may be determined, for example, by obtaining the high current battery voltage within a certain amount of time from the sensing module being powered on. For example, when the device wakes up (eg, following a button press), the device may increase withdrawal from the battery. In some embodiments, the device may initiate a boot process when waking up. The boot-up process may increase withdrawal from the battery due to, for example, various self-tests, boot operation, and the like. In some embodiments, when the device wakes up, it can take a magnetic measurement (eg, to determine a starting position of one or more components). Thus, this boot-up process and/or magnetic sensing can provide a high current battery voltage for measurement as the starting battery voltage.

A high current battery voltage can capture a high (eg, maximum) current peak that can be used to measure the voltage drop at that point, for example. The high current battery voltage can be determined, for example, by running the microcontroller at full speed and running all other loads in a low power mode for a predetermined time (eg, in milliseconds) and measuring the high current battery voltage. In some embodiments, the high current battery voltage is an average voltage calculated based on the set of measurements. In some embodiments, the high current battery voltage may be calculated at the beginning and/or end of the magnetic sensor activity. For example, the maximum voltage drop of the system may be obtained when the magnetic sensor(s) have completed the measurement.

The low current battery voltage can be used to measure the voltage drop with the lowest current load, for example, to simulate an open circuit voltage check on the battery. The low current battery voltage, for example, causes the firmware running on the MCU to put all loads (including the MCU) in a low power mode for a predetermined amount of time (eg, a sleep period specified in ms) and low current It can be determined by measuring the battery voltage. In some embodiments, the low current battery voltage is an average voltage calculated by averaging a set of measurements. In some embodiments, the low current battery voltage is determined after determining the high current battery voltage measurement.

As described herein, one or more voltage measurements may be used in step 402 . For example, in some embodiments, the voltages are representative open circuit voltage measurements for voltage readings at high and/or maximum current consumption (eg, the point with maximum voltage drop), and low/lowest current consumption. may be taken in a manner designated to obtain The voltages may be used to estimate remaining battery energy, as described herein. In some embodiments, techniques may estimate the remaining battery energy using, for example, a single voltage drop, such as a maximum voltage drop (eg, the maximum voltage drop depends on the battery state compared to other voltage drops). may be more dependent, since it may be more capacitive driven). For example, the power-supply/start-up voltage drop can be used to simply compare the maximum voltage drop. For example, if the voltage drop while being powered on is greater than the system's measured maximum drop, the comparison may indicate that the component is at risk of being reset.

Referring to step 406 , the device may store battery indication tables at various temperatures. For example, the device may store a set of low temperature battery indications including a set of battery indications each having an associated voltage for low temperature. Table 1 is an example of a set of low temperature battery indications (eg, at 0°C).

As another example, the device may store a set of high temperature battery indications including a set of high temperature battery indications each having an associated voltage for the high temperature. Table 2 is an example of a set of high temperature battery indications (eg, at 22-24° C.).

The sensing system may determine the set of temperature-adjusted battery indications based on the set of low temperature battery indications, the set of high temperature battery indications, and the temperature measurement(s) obtained in step 402 . In some embodiments, the sensing system may determine the correction factor based on the temperature measured in step 404 (eg, via firmware running on the MCU). For example, the sensing system may determine a correction factor based on the measured temperature and one or more correction factors. Logarithmic and/or linear relationships (shown below) can be developed to characterize the correction factors. For example, the sensing system may determine the correction factor using Equation (9).

here,

corrFactor is a correction factor,

A, B and C are coefficients (e.g., determined based on data collected to provide desired degrees of freedom for determining a correction factor);

LogOffset is a coefficient (eg determined based on data collected to provide desired degrees of freedom for determining a correction factor).

The sensing system may determine a set of corrected battery indications (eg, a calibrated battery table) based on the temperature correction factor. In some embodiments, the sensing system may determine calibrated battery indications based on both the low temperature and high temperature battery tables. For example, the sensing system may determine each corrected battery voltage associated with each indicator using Equation (10).

here,

corrBatCurve _x is the corrected battery curve voltage for row X,

·Voltage _TEMPHIx is the voltage for row X of the high temperature battery table,

·Voltage _TEMPLOx is the voltage for row X of the low temperature battery table,

TEMPHI is the temperature used to determine the high temperature battery table,

TEMPLO is the temperature used to determine the low temperature battery table,

?corrFactor is a correction factor determined using Equation (9).

Referring to step 408 , the device may determine a battery indicator based on a previous battery indicator. For example, the device obtains a previous battery indicator for the battery, determines a current battery indicator for the battery based on a set of temperature-adjusted battery indications and voltage measurements in a calibrated battery table, and determines the previous battery indicator and determine the battery indicator based on the current battery indicator.

In some embodiments, the sensing system may determine a current battery indicator based on stored battery tables and/or a calibrated battery table. For example, the sensing system may interpolate points in the calibrated battery table to the high current battery voltage (eg, measured in step 402 of FIG. 4 ). For example, if the high current battery voltage is equal to the voltage value in the table, the sensing system may determine that the battery indicator is the associated indicator for that row. As another example, if the high current battery voltage is between two voltage values in the table, the sensing system may interpolate the two associated battery indicators to determine the associated battery indicator.

In some embodiments, the sensing system may determine a new battery indicator based on a previous battery indicator (eg, which may be stored in storage of the sensing system, such as EEPROM). For example, the sensing system may determine a new battery indicator using Equation (11).

here,

newBatInd is the new battery indicator,

batInd is the old battery indicator (eg obtained from EEPROM),

curBatInd is the currently determined battery indicator,

·FILTER is the filter value. The FILTER is the last action associated with the sensing system (eg, synchronizing communication with a remote computing device, such as remote computing device 104 ), bonding events with the remote computing device, and/or administration administered by the associated medicament delivery device. may be determined based on the amount of time elapsed since the detection of .

The sensing system may store (eg, in EEPROM) the determined new battery indicator. In some embodiments, additional data such as timestamp, number of remaining injections, etc. may be stored in the new battery indicator. For example, the initial injection number may be configured by a new sensing system and/or a system associated with a new battery, the sensing system being configured to decrement the injection number for each sensed injection through the medicament delivery device. can

The apparatus may transmit a battery indicator to a remote device (eg, remote computing device 104 ). The remote device may process the new battery indicator. For example, the remote device may be configured to determine a battery status based on the battery indicator. For example, the following Table 3 illustrates example battery conditions and associated battery indicators.

In some embodiments, the first time the sensing device raises a low battery flag (eg, when the device is unlikely to be able to provide more than a certain number of injections, such as 120 injections), the sensing device is low. You can enter the battery state. When a sensing device enters a low battery state, it may avoid changing from a low battery state for that battery (eg, to avoid moving back and forth from a low battery state and a non-low battery state). In some embodiments, the sensing device may be configured to decrement the battery indicator by one for each new operation of the sensing device (eg, a synchronization, bonding or dosing event) once in a low power state. In some embodiments, the sensing device may be configured to decrement the remaining number of injections by one for each new operation of the sensing device, once in the low power state. When the battery indicator goes to zero, the sensing system may enter an end-of-life state. In some embodiments, the battery may be changed and the sensing system may be reset when detecting a new battery. In some embodiments, the sensing system is disposable and may be disposed of upon reaching an end-of-life condition.

In some embodiments, the sensing system may perform one or more checks on data obtained and/or measurements made during battery monitoring processes. For example, the MCU may raise a low battery alert when a new battery indicator falls below a predetermined threshold. As another example, the sensing system may check whether the sensed voltages are within predetermined acceptable ranges, whether the temperature measurement is within predetermined acceptable ranges, and the like.

As described herein, the techniques work with various types of medicament delivery devices, including medicament delivery devices incorporating aspects described herein, as well as add-on components that can be attached to the medicament delivery device. can be used For purposes of illustration, FIGS. 5-12 describe exemplary medicament delivery devices and dose sensing systems into which the techniques may be incorporated. These techniques are further discussed in PCT Application No. PCT/US19/18780, filed February 20, 2019, which is incorporated herein by reference.

5 and 6 illustrate an example medicament delivery device 10 in accordance with some examples. The medicament delivery device 10 is a pen injector configured to inject a medicament into a patient through a needle. The pen injector 10 includes a body 11 , which includes an elongate, pen-shaped housing 12 comprising a distal portion 14 and a proximal portion 16 . The distal portion 14 is received within the pen cap 18 . Referring to FIG. 6 , distal portion 14 contains a reservoir or cartridge 20 configured to hold a medical fluid of medicament dispensed through its distal outlet end during a dispensing operation. The outlet end of the distal portion 14 has a removable needle assembly 22 comprising an injection needle 24 surrounded by a removable cover 25 . A piston 26 is positioned within the reservoir 20 . An injection mechanism positioned within the proximal portion 16 is operative to advance the piston 26 toward the outlet of the reservoir 20 during a dose dispensing operation to force the contained medicament through the needle-like end. The injection mechanism includes a drive member 28 , exemplarily in the form of a screw, movable axially with respect to the housing 12 to advance the piston 26 through the reservoir 20 .

A dose setting member 30 is coupled to the housing 12 to set the dose dispensed by the device 10 . In the illustrated embodiment, the dose setting member 30 is in the form of a screw element that is helically operated (eg, moved simultaneously axially and rotationally) relative to the housing 12 during dose setting and dispensing. 5 and 6 illustrate the dose setting member 30 fully screwed into the housing 12 in its home or zero dose position. The dose setting member 30 is operable to be screwed proximally outwardly from the housing 12 until it reaches a fully extended position corresponding to the maximum dose that can be delivered by the device 10 in a single injection. do.

6-8 , the dose setting member 30 is a spiral that engages with a correspondingly threaded inner surface of the housing 12 such that the dose setting member 30 can be helical relative to the housing 12 . and a cylindrical dosing dial member 32 having a threaded outer surface of Dosing dial member 32 further includes a helical threaded inner surface that engages a threaded outer surface of sleeve 34 ( FIG. 6 ) of device 10 . The outer surface of the dial member 32 includes dosing indicator markings, such as numbers viewable through the dose window 36 to indicate to the user of a set dose. The dose setting member 30 is coupled within the open proximal end of the dial member 32 and is coupled to the dial member 32 by detents 40 received in openings 41 in the dial member 32 . and a tubular flange 38 that is axially and rotationally locked to the . The dose setting member 30 may further include a collar or skirt 42 positioned about the outer perimeter of the dial member 32 at the proximal end. Skirt 42 is axially and rotationally locked to dial member 32 by tabs 44 received in slots 46 . Examples of a skirtless device are shown in further embodiments described below.

Accordingly, the dose setting member 30 may be considered to include any or all of the dose dial member 32 , the flange 38 , and the skirt 42 , all of which are rotatably and axially. Because they are fixed together in the direction. The dosing dial member 32 is directly involved in the setting of dosing and the actuation of drug delivery. A flange 38 is attached to the dispensing dial member 32 and cooperates with a clutch to selectively couple the dial member 32 with the dispensing button 56 , as described below. Skirt 42 provides a surface external to body 11 so that a user can rotate dial member 32 to set dosing. For skirtless embodiments, dose button 56 includes an outer wall extending distally to define a surface to be rotated by a user.

Skirt 42 illustratively includes an annular ridge 49 and a plurality of surface features 48 formed on an outer surface of skirt 42 . Surface features 48 are exemplarily longitudinally extending ribs and grooves spaced circumferentially about the outer surface of skirt 42 and assisting a user to grip and rotate the skirt. )admit. In an alternative embodiment, skirt 42 is removed or integral with dial member 32 , and a user may grip and rotate dosing button 56 and/or dosing dial member 32 to set dosing. In the embodiment of FIG. 8 , the user may grip and rotate the radially outer surface of the integral dosing button 56 that also includes a plurality of surface features for dosing setting.

The transmission device 10 includes an actuator 50 having a clutch 52 received within a dial member 32 . Clutch 52 includes an axially extending stem 54 at its proximal end. The actuator 50 further includes a dose button 56 positioned proximally of the skirt 42 of the dose setting member 30 . The dispensing button 56 includes a collar 58 ( FIG. 6 ) located centrally on the distal surface of the dispensing button 56 . In order to axially and rotationally secure the dispensing button 56 and clutch 52 together axially and rotationally, a collar 58 may be attached to the stem of the clutch 52, eg, by interference fit or ultrasonic welding. (54) is attached.

The dispensing button 56 has a disc-shaped proximal end surface or face 60 and a distally extending and radially inwardly spaced apart outer peripheral edge of the face 60 to form an annular lip 64 therebetween. an annular wall portion 62 . The proximal face 60 of the dispensing button 56 serves as a pressing surface, and a force may be applied passively, ie directly by the user, against the pressing surface to depress the actuator 50 distally. there is. The dispensing button 56 illustratively includes a recessed portion 66 centered on the proximal face 60 , although the proximal face 60 may alternatively be a flat surface. A biasing member 68 , illustratively a spring, is disposed between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 , thereby engaging the actuator 50 and the dose setting member 30 . axially and away from each other. To initiate the dose dispensing action, the dose button 56 may be pressed by the user.

The delivery device 10 can be operated in both a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, the dose setting member 30 is dialed (rotated) relative to the housing 12 to set the desired dose to be delivered by the device 10 . Dialing in the proximal direction serves to increase the set dose and dialing in the distal direction serves to decrease the set dose. The dose setting member 30 may be adjusted during a dose setting operation in rotational increments (eg, clicks) that correspond to a minimal incremental increment or decrement of the set dose. For example, one increment or "click" may be equal to 1/2 or 1 unit of drug. The set dose may be visible to the user via dial indicator markings visible through the dose window 36 . Actuator 50 , including dose button 56 and clutch 52 , is moved axially and rotationally with dose setting member 30 during dialing in dose setting mode.

The dosing dial member 32 , the flange 38 , and the skirt 42 are all rotationally secured with respect to each other, and due to the threaded connection of the dosing dial member 32 and the housing 12 , medicament delivery during dosing setup It rotates and extends proximally to device 10 . During this dose setting movement, the dose button 56 is pressed together by a biasing member 68, the skirt 42 by means of complementary splines 74 of the flange 38 and clutch 52 (FIG. 6). ) is rotationally fixed with respect to During the course of dosing setup, skirt 42 and dosing button 56 are moved relative to housing 12 in a helical fashion from a “start” position to an “end” position. This rotation relative to the housing is proportional to the dose set by the operation of the medicament delivery device 10 .

Once the desired dose is established, the device 10 is manipulated such that the injection needle 24 properly penetrates, for example, the user's skin. In response to an axial distal force applied to the proximal face 60 of the dispense button 56 , a dose dispensing mode of operation is initiated. The axial force is applied directly to the dispensing button 56 by the user. This causes axial movement of the actuator 50 relative to the housing 12 along the distal direction.

The axial movement motion of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dispensing button 56 and the tubular flange 38 . This relative axial movement separates the complementary splines 74 on the clutch 52 and flange 38 , and thereby the actuator 50 , eg, from rotationally secured to the dose setting member 30 . , disengages the dosing button 56 . In particular, the dose setting member 30 is rotationally uncoupled from the actuator 50 , allowing for reverse driven rotation of the actuator 50 and the dose setting member 30 relative to the housing 12 . The dose dispensing mode of operation may also be initiated by activating a separate switch or trigger mechanism.

As the actuator 50 can still be fitted in the axial direction without rotation about the housing 12 , the dial member 32 , as rotated relative to the dispense button 56 , is rotated back into the housing 12 . screwed up Dosage markings indicating that there is still an amount to be injected can be seen through window 36 . As the dose setting member 30 is threaded distally downward, the drive member 28 is advanced distally, pushing the piston 26 through the reservoir 20 and dispensing the medicament with the needle 24 ( FIG. 6 ). ) is emitted through

During a dose dispensing operation, the amount of drug released from the medicament delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50 when the dial member 32 is screwed back into the housing 12 . do. When the internal threading of the dial member 32 has reached the distal end of the corresponding external threading of the sleeve 34 (FIG. 6), the injection is complete. The device 10 is then once again arranged in a ready state or zero dosing position, as shown in FIGS. 6 and 7 .

The start and end angular positions of the dosing dial member 32 relative to the dosing button 56, and thus the rotatably fixed flange 38 and skirt 42, provide an “absolute” change in angular positions during delivery of a dose. . Determining whether the relative rotation has exceeded 360° is determined in a number of ways. By way of example, the total rotation may be determined by also taking into account incremental movements of the dose setting member 30 , which may be measured in any number of ways by the sensing system.

Various sensor systems are contemplated herein. In general, sensor systems include a sensing component and a sensing component. The term “sensing component” refers to any component capable of detecting the relative position of a sensed component. A sensing component includes a sensing element or “sensor,” along with associated electrical components for operating the sensing element. A “sensed component” is any component that is capable of detecting the position and/or movement of the sensed component relative to the sensing component. In a dose delivery detection system, a sensing component is rotated relative to the sensing component, and the sensing component can detect an angular position and/or rotational movement of the sensing component. For a dose type detection system, the sensing component detects the relative angular position of the component being sensed. The sensing component may include one or more sensing elements, and the sensed component may include one or more sensed elements. The sensor system may detect a position or movement of the sensed component(s) and provide outputs indicative of the position(s) or movement(s) of the sensed component(s).

The sensor system typically detects a characteristic of the sensed parameter that changes with respect to the position of one or more sensed elements within the sensed area. The sensed elements extend or otherwise affect the sensed area in a manner that directly or indirectly affects the characteristic of the sensed parameter. Since the relative positions of the sensor and the sensed element affect the properties of the sensed parameter, a microcontroller unit (MCU) of the sensor system can determine different rotating positions of the sensed element.

Suitable sensor systems may include a combination of active and passive components. If the sensing component operates as an active component, neither component needs to be connected to a power supply or other system elements such as an MCU.

Any of a variety of sensing techniques may be incorporated in which the relative positions of the two members may be detected. Such techniques may include, for example, techniques based on tactile, optical, inductive or electrical measurements. These techniques may include measurement of a sensed parameter associated with a field, such as a magnetic field. In one form, the magnetic sensor senses a change in the sensed magnetic field as the magnetic component is moved relative to the sensor. In another embodiment, the sensor system may sense changes to the magnetic field and/or characteristics of the magnetic field when an object is positioned within and/or moved through the magnetic field. Changes in the field change the characteristic of the sensed parameter in relation to the position of the sensed element in the sensed area. In such embodiments, the sensed parameter may be capacitance, conductance, resistance, impedance, voltage, inductance, or the like. For example, a magneto-resistive type sensor detects a distortion of an applied magnetic field that produces a change in the characteristic resistance of an element of the sensor. As another example, Hall effect sensors detect changes in voltage generated from distortions of an applied magnetic field.

In one aspect, the sensor system detects the relative positions or movements of the sensed elements, and thus the associated members of the medicament delivery device. The sensor system generates outputs indicative of the position(s) or amount of movement of the sensed component. For example, the sensor system may be operable to generate outputs by which rotation of the dose setting member may be determined during dose delivery. The MCU is operatively coupled to each sensor to receive the outputs. In an aspect, the MCU is configured to determine from the outputs a dose delivered by operation of the medicament delivery device.

A dose delivery detection system includes detecting relative rotational movement between two members. In a range of rotation that has a known relationship to the delivered dose, the sensor system is operated to detect the amount of angular movement from the start of the dose infusion to the end of the dose infusion. For example, a typical relationship for a pen injector would be an angular displacement of the dose setting member of 18° equals a unit of dose of 1, although other angular relationships are also suitable. The sensor system may be operable to determine a total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, 5 units of dosing have been delivered.

One approach for detecting angular displacement is to count the increments of the doses as the infusion proceeds. For example, the sensor system may use a repeating pattern of sensed elements such that each iteration is an indication of a predetermined degree of angular rotation. Conveniently, a pattern can be established such that each iteration corresponds to the smallest increment of administration that can be set with the medicament delivery device.

An alternative approach is to detect the start and stop positions of the relatively moving member and determine the delivered dose as the difference between those positions. In this approach, part of the determination may be for the sensor system to detect the total number of rotations of the dose setting member. Various methods for this are within the ordinary skill in the art and may include “counting” the number of increments to estimate the total number of revolutions.

The sensor system components may be permanently or removably attached to the medicament delivery device. In an exemplary embodiment, at least some of the dose detection system components are provided in the form of modules that are removably attached to the medicament delivery device. This has the advantage of allowing these sensor components to be used in more than one pen injector.

In some embodiments, the sensing component is mounted to the actuator and the sensing component is attached to the dose setting member. The sensed component may also include a dose setting member or any portion thereof. The sensor system detects the relative rotation of the sensed component and thus of the dose setting member during dose delivery, from which the dose delivered by the medicament delivery device is determined. In an exemplary embodiment, a rotation sensor is attached to, and rotationally secured to, the actuator. The actuator is not rotated relative to the body of the medicament delivery device during dose delivery. In this embodiment, the sensed component is attached to, and rotationally secured to, a dose setting member that rotates relative to the actuator and device body during dose delivery. The sensed component may also include a dose setting member or any portion thereof. In an exemplary embodiment, the rotation sensor is not directly attached to a relatively rotating dose setting member during dose delivery.

Referring to FIG. 9 , shown in schematic form is a dose delivery detection system 80 that includes an example of a module 82 useful with a medicament delivery device such as device 10 . Module 82 generally carries a sensor system, shown as a rotation sensor 86 (or two or more rotation sensors), and other associated components such as a processor, memory, battery, and the like. Module 82 is provided as a separate component that can be removably attached to an actuator.

The dose detection module 82 includes a body 88 attached to a dose button 56 (shown in dashed lines). The body 88 illustratively includes a cylindrical sidewall 90 and a top wall 92 which spans and seals the sidewall 90 . In an aspect where module 82 can be removed from a first medicament delivery device and thereafter attached to a second medicament delivery device, dose detection module 82 may alternatively be a snap fitting or press fit, threaded interface, etc. It may be attached to the dispense button 56 via any suitable fastening means, such as As discussed herein, the attachment may be at any location on the dose button 56 as long as the dose button 56 can be moved axially relative to the dose setting member 30 by any desired amount. .

During dose delivery, dose setting member 30 is freely rotated relative to dose button 56 and module 82 . In the exemplary embodiment, the module 82 is rotationally secured with the dose button 56 and is not rotated during dose delivery. This may engage mutually-facing splines or other surface features on the module body 88 and the dispense button 56 , for example, with tabs or upon axial movement of the module 82 relative to the dispense button 56 . By doing, it can be provided structurally. In another embodiment, distal depression of the module provides sufficient frictional engagement between module 82 and dispensing button 56 such that, functionally, module 82 and dispensing button 56 rotate together during dose delivery. to remain fixed.

The top wall 92 is spaced from the face 60 of the dispense button 56 and thereby provides a cavity 96 , in which some or all of the rotation sensor and other components may be contained. Cavity 96 may be open at the bottom or may be closed by, for example, bottom wall 98 . The bottom wall 98 may be positioned to bear directly against the face of the dispense button 56 . Alternatively, a bottom wall 98 (if present) can be spaced from the dispensing button 56 , such that an axial force applied to the module 82 is transmitted to the dispensing button 56 . Other contacts between and dispense button 56 may be used. In other embodiments, module 82 may be rotationally secured to an integral dispensing button configuration.

In an alternative embodiment, the module 82 during dose setting is attached to the dose setting member 30 instead. For example, the sidewall 90 may include a lower wall portion 100 having inwardly directed projections in the form of coupling arms 102 that engage a button sidewall. In this approach, the module 82 can effectively engage the proximal face 60 of the dispense button 56 and the distal side of the annular ridge 49 . In this configuration, the lower wall portion 100 may be provided with surface features that engage the surface features of the dispense button to rotationally secure the module 82 with the dispense button. Thereby, the rotational forces applied to the housing 82 during dosing setup are transmitted to the dosing button by the coupling of the lower wall portion 100 and the side wall of the dosing button. Light guide 118 is shown disposed between LEDs 114A-C and light sensor 110 , collectively shown in a single location on the electronic assembly, and face (if present) of dose button 56 . has been A battery 138 is shown disposed over a portion of the optical system 89 and electronic assembly.

The example electronic assembly 120 includes a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronic assembly includes a sensor system including one or more rotation sensors 86 in operative communication with a processor to receive signals from the sensor indicative of a sensed relative rotation. The electronic assembly further includes an MCU including at least one processing core and an internal memory. An example of an electronic assembly schematic is shown in FIG. 1B .

10A, 10B, 11A and 11B , an exemplary magnetic sensor system including an annular, ring-shaped, bipolar magnet 152 having a north pole 154 and a south pole 156 as a sensed element (150) is shown. The magnets described herein may also be referred to as a diametrically magnetized ring. A magnet 152 is attached to the flange 38 and thus rotates with the flange during dose delivery. The magnet 152 may be alternately attached to the dosing dial 32 , or other members that are rotatably secured to the dose setting member. The magnet 152 may be constructed of various materials such as rare earth magnets, for example, neodymium, and the like.

The sensor system 150 further includes a measurement sensor 158 that includes one or more sensing elements 160 operatively coupled with sensor electronics (not shown) housed within the module 82 . The sensing elements 160 of the sensor 158 are shown attached to a printed circuit board 162 , which is a turn attached module 82 that is rotationally secured to a dose button 56 , in FIG. 11A . . Consequently, the magnet 152 rotates relative to the sensing elements 160 during dose delivery. The sensing elements 160 are operable to detect the relative angular position of the magnet 152 . Sensing elements 160 may include inductive sensors, capacitive sensors, or other contactless sensors when ring 152 is a metal ring. Thereby, the magnetic sensor system 150 is operative to detect the total rotation of the flange 38 relative to the dose button 56 , and thus rotation relative to the housing 12 during dose delivery. In one example, a magnetic sensor system 150 including a sensor 158 having a magnet 152 and sensing elements 160 may be arranged in modules.

In one embodiment, magnetic sensor system 150 includes four sensing elements 160 spaced equi-radially within module 82 to define a ring pattern as shown. . Alternate numbers and positions of sensing elements may be used. For example, in another embodiment shown in FIG. 11B , a single sensing element 160 is used. Also, although the sensing element 160 of FIG. 11B is shown centered within the module 82, other locations may be used. 12, for example, there are five sensing elements 906 equi-circumferentially and equi-radially spaced within the module. In the embodiments described above, the sensing elements 160 are shown attached within the module 82 . Alternatively, the sensing elements 160 may be attached to any portion of the component that is rotationally secured to the dose button 56 , such that the component does not rotate relative to the housing 12 during dose delivery.

For purposes of illustration, magnet 152 is shown as a single annular bipolar magnet attached to flange 38 . However, alternative configurations and locations of magnet 152 are contemplated. For example, a magnet may include multiple poles, such as alternating north and south poles. In one embodiment, the magnet includes a number of pole pairs equal to the number of distinct rotating dose-setting positions of the flange 38 . Magnet 152 may also include multiple individual magnet members. In addition, the magnet component may be attached to any portion of a member that is rotationally secured to the flange 38 during dose delivery, such as the skirt 42 or dosing dial member 32 .

Alternatively, the sensor system may be an inductive or capacitive sensor system. A sensor system of this kind uses a sensing element comprising a metal band attached to a flange similar to the attachment of a magnetic ring described herein. The sensor system further comprises one or more sensing elements, such as four, five, six or more independent antennas or armatures spaced equi-angularly along the distal wall of the module housing or pen housing. include These antennas form pairs of antennas positioned 180 degrees or other angles apart and provide a ratio-metric measurement of the angular position of the metal ring relative to the delivered dose.

The metal band ring is formed such that one or more distinct rotating positions of the metal ring relative to the module can be detected. The metal band has a shape that produces various signals upon rotation of the metal ring relative to the antennas. The antennas are operatively connected with the electronic assembly such that, during delivery of a dose, the antennas function to detect positions of the metal ring relative to the sensors and thus to the housing 12 of the pen 10 . The metal band may be a single cylindrical band attached to the outside of the flange. However, alternative configurations and locations of the metal band are contemplated. For example, the metal band may include a number of individual metal elements. In one embodiment, the metal band includes a number of elements equal to the number of individually rotating dosing-setting positions of the flange. An alternative metal band may be attached to any portion of a component that is rotationally secured to flange 38 during dose delivery, such as dial member 32 . The metal band may include a metal element attached to a member that rotates on the inside or outside of the member, or this may be done, for example, by metal particles incorporated into the component, or by over-molding the component into the metal band. It can be incorporated into these members. The MCU is operable to determine the position of the metal ring with the sensors.

The MCU determines the starting position of the magnet 152 by averaging the number (eg, four) of the sensing elements 160 at the maximum sampling rate according to a standard quadrature differential signals calculation. It is possible to operate. During the dose delivery mode, sampling may be performed at a frequency targeted by the MCU to detect the number of rotations of the magnet 152 . At the end of the dose delivery, the MCU determines the final position of the magnet 152 by averaging the number (eg, four) of the sensing elements 160 at the maximum sampling rate according to the standard quadrature differential signals calculation. It is possible to operate. The MCU is operable to determine the number of revolutions and the final position from the calculation of the total rotational movement angle from the determined starting position. The MCU is operable to determine the number of dosing steps or units by dividing the total rotational movement angle by a predetermined number (eg, 10, 15, 18, 20, 24, etc.) correlating with the design and medicament of the device.

With further reference to FIG. 12 , FIG. 12 illustrates another example of a magnetic sensor system 900 that includes a diametrically magnetized ring 902 having a north pole 903 and a south pole 905 as a sensed element. The magnetizing ring 902 is attached to a dose setting member, such as a flange, for example, as previously described. For example, the radial displacement of magnetic sensors 906 , such as Hall-effect sensors with respect to magnetizing ring 902 , may be equiangular with respect to each other in the ring pattern. In one example, the magnetic sensors 906 are positioned at an outer circumferential edge 902A of the magnetization ring 902 such that a portion of the magnetic sensor 906 is above the magnetization ring 902 and the remainder is external of the magnetization ring 902 . It is arranged in a radial direction in an overlapping relationship with .

In some embodiments, the sensing system is configured to determine whether the sensing system is coupled to the medicament delivery device. 13 shows an example computerized method 1300 for determining whether an apparatus is removably coupled to a medicament injection device in accordance with some embodiments. A sensing system, such as a dose delivery detection system, includes a plurality of sensing elements. For example, the sensing system includes a plurality of sensing elements within the device, such as four or five sensing elements equi-circumferentially and equi-radially spaced apart. As described herein, the plurality of sensing elements may include a plurality of Hall effect sensors. In some embodiments, the five Hall effect sensors are equally spaced 72 degrees apart around a circle having a diameter designed based on the magnetic component of the medicament delivery device being sensed. For example, using a diameter of approximately 14 mm, we can cause the sensors to assert an envelope described by the maximum value of the Z component of the magnetic field as the magnet rotates about its axis. The sensing system also includes a processor (eg, MCU) in communication with the set of sensing elements.

The sensing system (via its processor, MCU, etc.) is configured to execute computer readable instructions causing the processor to execute the computerized method 1300 . In step 1302, the sensing system obtains a set of voltage measurements from each of a plurality of sensing elements. At step 1304 , the sensing system determines two-dimensional data representative of a magnetic field of a magnetic component of the medicament injection device. In step 1306, the sensing system determines one-dimensional data based on the two-dimensional data. At step 1308 , the sensing system determines, based on the one-dimensional data, whether the set of voltage measurements indicates that the apparatus is coupled to a medicament injection device.

Referring to step 1302 , when the power button on the sensing system is pressed by the user, the sensing system wakes up and firmware running on the processor (eg, before any rotation occurs) Switch on the sensing elements (eg magnetic sensors) to assume the starting position of the magnetic component of the transfer device. During this phase, it is important to take the readings of the sensors immediately after wake-up to avoid taking measurements during rotation. In some embodiments, the sensing system may average the number of samples of each sensor (eg, 5, 10, 15, etc. of each sensor) to, for example, reduce noise .

Referring to step 1304 , in some embodiments, the sensing system determines a quadrature signal comprising an inphase (I) portion and a quadrature (Q) portion. The system may determine the I and Q values based on the sum of the respective sensor values. In some embodiments, the sensing system uses the coefficients when summing the sensor values. For example, the system may store one or more coefficients for each sensor. In some embodiments, the sensing system comprises one coefficient for each sensor multiplied by the sensor value during summing to determine an I value, and a second coefficient for each sensor multiplied by the sensor value during summing to determine a value. 2 Store the coefficients. In some embodiments, the coefficients may be used to combine the results of multiple sensors (eg, 5 sensors equally spaced 72 degrees apart from each other, etc.) for I and Q calculation. In some embodiments, the coefficients are a system of equations that force the results of the quadrature calculation to have an error of zero relative to the nominal angle prior to offset in the measured signal, second harmonic distortion, third harmonic distortion, etc. It can be obtained by solving

Referring to step 1306 , in some embodiments, the sensing system determines a scale factor based on the two-dimensional signal (eg, an orthogonal signal) determined at step 1304 . In some embodiments, the sensing system determines the scale factor based on the quadrature signal and one or more of a predetermined offset and a predetermined gain. For example, the processor may determine the scale factor based on Equation 12 below.

here,

ScaleFactor is a scale factor,

I is the in-phase part of the orthogonal signal,

Q is the orthogonal part of the orthogonal signal,

OI is the offset measured from the I signal during calibration,

OQ is the offset measured from the Q signal during calibration,

GI is the gain measured on the I signal during calibration,

·GQ is the gain measured on the Q signal during calibration.

These exemplary I and Q offsets and gains can be used because orthogonality works well when I and Q are well balanced, for example when the offset equals 0 and the gain equals 1. . The calibration process can be used to determine offsets/gains that balance the measured I and Q to achieve sufficient values, thereby removing skew between I and Q, etc. In some embodiments, the sensing system may be configured to normalize the I and Q values, and use the I and Q values to determine a normalized angle of the Z component of the magnetic field. After the dose is administered, the sensing system can then monitor the end position of the magnetic component of the medicament delivery device to determine the dose injected (eg, rotation of the magnet using similar techniques described herein). monitor and/or determine the end position of the magnet).

Referring to step 1308 , the sensing system may determine whether the one-dimensional data indicates that the sensing system is coupled (or not coupled) to the medicament delivery device. The sensing system may use the scale factor to determine whether the sensing system is mounted to or coupled to the medicament delivery device. For example, if the scale factor is between predetermined thresholds, the sensing system may determine that the sensing system is mounted on the medicament delivery device. If the scale factor is not between predetermined thresholds, the sensing system may determine that the sensing system is likely not mounted on the medicament delivery device. In some embodiments, the sensing system is configured to determine whether the magnet the module is monitoring is an expected magnet (eg, +/-25% of its nominal perimeter is acceptable) such that only a desired amplitude is accepted by the module. You can check the scale factor for low amplitude margin and high amplitude margin.

Dosage detection systems have been described with specific designs of medicament delivery devices, such as pen injectors, as examples. However, the exemplary dose detection systems may also be used with alternative medicament delivery devices, and other sensing configurations operable in the manner described herein. For example, any one or more of the various sensing and switch systems may be omitted from the module.

The various methods or processes described herein may be coded as software executable on one or more processors employing any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and/or programming or scripting tools, and may also be compiled as executable machine language code or intermediate code running in a virtual machine or suitable framework. can be

In this regard, various inventive concepts relate to at least one non-transitory computer-readable storage medium (eg, one or more non-transitory computer-readable storage media (e.g., for example, computer memory, one or more floppy disks, compact disks, optical disks, magnetic tape, flash memory, circuit configurations of Field Programmable Gate Arrays or other semiconductor devices, etc.). The non-transitory computer readable medium or media may be transportable such that the program or programs stored thereon may be loaded onto any computer resource to implement various aspects of the invention as discussed above.

The terms “program,” “software,” and/or “application” refer herein to a set of computer-executable instructions or a set of computer-executable instructions that may be employed to program a computer or other processor to implement various aspects of the embodiments as discussed above. It is used in its generic sense to refer to any type of computer code. Additionally, according to an aspect, one or more computer programs for performing the methods of the present invention, when executed, need not reside on a single computer or processor, but between different computers or processors implementing various aspects of the present invention. It should be understood that it may be distributed in a modular manner.

Computer-executable instructions can take many forms, such as program modules, being executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of program modules may be combined or distributed as desired in various embodiments.

Also, data structures may be stored in non-transitory computer-readable storage media in any suitable form. Data structures can have fields that are related through the location of the data structure. These relationships may likewise be achieved by allocating storage for the fields to locations on a non-transitory computer-readable medium that conveys the relationship between the fields. However, any suitable mechanism may be used to establish relationships between information in fields of a data structure, including through the use of pointers, tags, or other mechanisms for establishing relationships between data elements.

Various inventive concepts may be embodied in one or more ways, examples of which are provided. The tasks performed as part of the method may be arranged in any suitable manner. Thus, although embodiments are shown as sequential operations in the exemplary embodiments, operations may consist of performing operations in a different order than illustrated, which may include performing some operations concurrently.

As used herein in the specification and claims, the indefinite articles “a” and “an” should be understood to mean “at least one” unless clearly indicated to the contrary. As used herein, in the specification and claims, the phrase “at least one” in reference to a list of one or more elements is understood to mean at least one element selected from any one or more of the elements of the list of elements. However, it need not necessarily include at least one of each and every element specifically recited in the list of elements, nor need to exclude any combinations of elements of the list of elements. This allows elements other than those specifically identified within the list of elements to which the phrase "at least one" refer, whether or not related to those specifically identified elements, to be arbitrarily present.

As used herein in the specification and claims, the phrase "and/or" refers to "either one of the elements so combined, that is, in some cases present in combination and in other cases separately present." or both". Multiple elements listed as “and/or” should be construed in the same way, ie, “one or more” of the elements so combined. Elements other than those specifically identified by the "and/or" clause may optionally be present, with or without relationship to those elements specifically identified. Thus, as a non-limiting example, reference to "A and/or B", when used in conjunction with an open language such as "comprising," may, in one embodiment, refer only to A (optionally (including elements other than B), in other embodiments, mentioning only B (optionally including elements other than A), and in still other embodiments, referring to both A and B (optionally including elements other than A) to include other elements), and so forth.

As used herein in the specification and claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, "or" or "and/or" should be construed as inclusive, ie, inclusive of at least one, as well as two or more of a plurality of elements or lists of elements. , and, optionally, additionally not listed items. Only terms expressly indicated to the contrary, such as "only one of" or "exactly one of" or, as used in the claims, "consisting of" refer to a plurality of elements or exactly one element of a list of elements. may be referred to as comprising. In general, the term "or" as used herein refers to exclusive alternatives ( that is, "one or the other, but not both"). As used in the claims, “consisting essentially of” shall have its ordinary meaning as used in the field of patent law.

The use of ordinal terms such as "first", "second", "third", etc. in the claims to modify a claim element does not itself constitute any priority, precedence, or order of one claim element which differs from the claim element. It does not imply superiority to the order of elements or the temporal order in which the operations of the method are performed. These terms are used simply as labels to distinguish one claim element having a particular name from another element having the same name (except for the use of an ordinal term).

The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Uses of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof, refer to the items listed thereafter. and additional items.

Although several embodiments of the present invention have been described in detail, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to be within the spirit and scope of the present invention. Accordingly, the foregoing description is illustrative only and is not intended to be limiting.

Claims (42)

A device configured to determine lighting data representative of a color of an object, the apparatus comprising:
a set of light emitting diodes (LEDs) in optical communication with the object;
an optical sensor in optical communication with the object;
a processor configured to execute computer readable instructions
including,
The computer readable instructions cause the processor to:
cause the light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs;
adjusting the lighting data based on a temperature associated with the object; and
normalizing the lighting data set based on a normalization parameter set.
to process the lighting data to produce processed lighting data, comprising one or more of:
and transmit the processed lighting data to a remote device using a communication module in communication with the processor. The apparatus of claim 1 , wherein the light sensor is an ambient light sensor. 3. The apparatus of claim 1 or 2, wherein the object is part of the medicament delivery device that can be used to identify an aspect of the medicament delivery device based on the color of the object. 4. The method according to any one of claims 1 to 3,
a light guide disposed between (a) the set of LEDs, the light sensor, or both and (b) the object
A device further comprising a. 5. The method of any one of claims 1 to 4, wherein causing the light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs comprises:
first illumination data when the object is not illuminated by the set of LEDs, and
second illumination data when the object is illuminated by each LED of the LED set
A device comprising capturing 6. The method of claim 5,
The LED set includes a red LED, a blue LED and a green LED,
causing the light sensor to capture the second illumination data comprises:
(a) third illumination data when the object is illuminated by the red LED;
(b) fourth illumination data when the object is illuminated by the green LED, and
(c) fifth illumination data when the object is illuminated by the green LED
to capture
A device comprising a. A method for determining illumination data indicative of a color of an object, the apparatus comprising: a set of light emitting diodes (LEDs) in optical communication with the object, a light sensor in optical communication with the object;
causing the light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs;
adjusting the lighting data based on a temperature associated with the object; and
normalizing the lighting data set based on a normalization parameter set.
processing the lighting data to generate processed lighting data, comprising one or more of:
transmitting the processed lighting data to a remote device using a communication module in communication with the processor;
How to include. 8. The method of claim 7, wherein causing the light sensor to capture illumination data of the object while the object is illuminated by the set of LEDs comprises:
first illumination data when the object is not illuminated by the set of LEDs, and
second illumination data when the object is illuminated by each LED of the LED set
and causing the capture of 9. The method of claim 8,
The LED set includes a red LED, a blue LED and a green LED,
The step of causing the optical sensor to capture the second illumination data includes:
(a) third illumination data when the object is illuminated by the red LED;
(b) fourth illumination data when the object is illuminated by the green LED, and
(c) fifth illumination data when the object is illuminated by the green LED
steps to capture
A method comprising 10. The method according to any one of claims 7 to 9,
the light sensor is an ambient light sensor,
the object is a part of the medicament delivery device that can be used to identify an aspect of the medicament delivery device based on the color of the object;
A light guide is disposed between (a) the set of LEDs, the light sensor, or both and (b) the object. An apparatus configured to process lighting data to determine a color associated with the lighting data,
a processor configured to execute computer readable instructions
including,
The computer readable instructions cause the processor to:
generate a set of lighting metrics based on captured lighting data of the object under the lighting of the set of LEDs;
compare the set of lighting metrics to a set of stored representative lighting metrics, wherein each set of representative lighting metrics is associated with a color for determining a closest matching set of representative lighting metrics;
determine whether the lighting data is associated with a color associated with the set of representative lighting metrics based on a closest matching set of the representative lighting metrics. The apparatus of claim 11 , wherein the computer readable instructions further cause the processor to receive the lighting data from a communication module in communication with the processor. 13. The method of claim 11 or 12,
generating the set of lighting metrics comprises generating a lightness metric, a red/green metric, and a yellow/blue metric;
wherein each set of stored representative lighting metrics includes an associated brightness metric, a red/green metric, and a yellow/blue metric. 14. The method of any one of claims 11-13, wherein comparing the set of lighting metrics to the set of representative lighting metrics comprises:
determining a set of sigma distances, comprising, for each set of representative lighting metrics, determining a sigma distance for the set of lighting metrics;
determining that the lowest sigma distance is the closest matching sigma distance based on a lowest sigma distance and a second lowest sigma distance of the set of sigma distances;
A device comprising a. 15. The method according to any one of claims 11 to 14,
receiving a new set of representative lighting metrics; and
updating the stored representative metric set to include the new representative lighting metric set.
A device further comprising a. A method for processing lighting data to determine a color associated with the lighting data, the method comprising:
generating a set of lighting metrics based on captured lighting data of the object under the lighting of the LED set;
comparing the set of lighting metrics to a set of stored representative lighting metrics, wherein each set of representative lighting metrics is associated with a color for determining a closest matching set of representative lighting metrics;
determining that the lighting data is associated with a color associated with the set of representative lighting metrics based on a closest matching set of the representative lighting metrics;
How to include. 17. The method of claim 16,
receiving the lighting data from a communication module in communication with a processor;
How to include more. 18. The method of claim 16 or 17,
generating a set of lighting metrics includes generating a brightness metric, a red/green metric, and a yellow/blue metric;
wherein each set of stored representative lighting metrics includes an associated brightness metric, a red/green metric, and a yellow/blue metric. 19. The method of any one of claims 16 to 18, wherein comparing the set of lighting metrics to the set of representative lighting metrics comprises:
determining a set of sigma distances comprising, for each set of representative lighting metrics, determining a sigma distance for the set of lighting metrics;
determining that the lowest sigma distance is a closest matching sigma distance based on a lowest sigma distance and a second lowest sigma distance of the set of sigma distances;
A method comprising 20. The method according to any one of claims 16 to 19,
receiving a new set of representative lighting metrics; and
updating the stored representative metric set to include the new representative lighting metric set;
How to include more. A device configured to determine a battery indicator indicating the remaining life of the battery;
battery,
temperature sensing module,
A processor in communication with the battery and the temperature sensing module
including,
the processor is configured to execute computer readable instructions;
The computer readable instructions cause the processor to:
obtain a set of voltage measurements of the battery;
through the temperature sensing module to obtain a temperature measurement,
determine a temperature-adjusted set of battery indications based on the temperature measurement;
and determine a battery indicator indicative of a remaining life of the battery based on the temperature-adjusted battery indication and the set of voltage measurements. 22. The method of claim 21, wherein obtaining the set of voltage measurements comprises:
when the device is powered on, obtaining a starting battery voltage;
obtaining a high current battery voltage when the processor is running at full speed; and
obtaining a low current battery voltage when the processor is running in a low power mode;
A device comprising a. 23. The method of claim 21 or 22, wherein determining the set of temperature-adjusted battery indications based on the temperature measurement comprises:
low temperature battery indication set, and
High Temperature Battery Indicator Set
to store, and
determining the temperature-adjusted battery indication set based on the low temperature battery indication set, the high temperature battery indication set, and the temperature measurement.
including,
each low temperature battery indication comprises a battery indication for low temperature and an associated voltage;
wherein each high temperature battery indication includes a battery indication for high temperature and an associated voltage. 24. The method of claim 23, wherein determining a battery indicator indicative of the remaining life of the battery comprises:
obtaining a previous battery indicator for the battery;
determining a current battery indicator for the battery based on the temperature-adjusted battery indication and the set of voltage measurements;
determining the battery indicator based on the previous battery indicator and the current battery indicator
A device comprising a. 24. The apparatus of any of claims 21-23, further comprising transmitting the battery indicator to a remote device. A method for determining a battery indicator indicative of a remaining life of a battery, the apparatus comprising: a battery, a temperature sensing module, a processor in communication with the battery and the temperature sensing module;
obtaining a set of voltage measurements of the battery;
obtaining, through the temperature sensing module, a temperature measurement;
determining a temperature-adjusted set of battery indications based on the temperature measurements; and
determining a battery indicator indicative of the remaining life of the battery based on the temperature-adjusted battery indication and the set of voltage measurements;
How to include. 27. The method of claim 26, wherein obtaining the set of voltage measurements comprises:
when the device is powered on, obtaining a starting battery voltage;
when the processor is running at full speed, obtaining a high current battery voltage; and
obtaining a low current battery voltage when the processor is running in a low power mode;
A method comprising 28. The method of claim 26 or 27, wherein determining the set of temperature-adjusted battery indications based on the temperature measurement comprises:
low temperature battery indication set, and
High Temperature Battery Indicator Set
storing the; and
determining the temperature-adjusted battery indication set based on the low temperature battery indication set, the high temperature battery indication set, and the temperature measurement;
including,
each low temperature battery indication comprises a battery indication for low temperature and an associated voltage;
wherein each high temperature battery indication comprises a battery indication for high temperature and an associated voltage. 29. The method of claim 28, wherein determining a battery indicator indicative of the remaining life of the battery comprises:
obtaining a previous battery indicator for the battery;
determining a current battery indicator for the battery based on the temperature-adjusted battery indication and the set of voltage measurements;
determining the battery indicator based on the previous battery indicator and the current battery indicator
A method comprising 30. The method according to any one of claims 26 to 29,
transmitting the battery indicator to a remote device;
How to include more. an apparatus configured to determine whether removably coupled to a medicament injection device,
a plurality of sensing elements;
a processor in communication with the set of sensing elements
including,
the processor is configured to execute computer readable instructions;
The computer readable instructions cause the processor to:
obtain a set of voltage measurements from each of the plurality of sensing elements;
determine two-dimensional data representative of a magnetic field of a magnetic component of the medicament injection device;
to determine one-dimensional data based on the two-dimensional data,
and determine whether the set of voltage measurements is indicative of the device being coupled to the medicament injection device based on the one-dimensional data. 32. The apparatus of claim 31, wherein determining the two-dimensional data comprises determining a quadrature signal comprising an inphase portion and a quadrature portion. 33. The apparatus of claim 32, wherein determining the one-dimensional data comprises determining a scale factor based on the orthogonal signal. 34. The apparatus of claim 33, wherein determining the scale factor comprises determining the scale factor based on the orthogonal signal and one or more of a predetermined offset and a predetermined gain. 35. The sensing element of any one of claims 31 to 34, wherein the plurality of sensing elements are five sensing elements spaced equi-circumferentially and equi-radially within the device. A device comprising an element. 36. The apparatus of any of claims 31-35, wherein the plurality of sensing elements comprises a plurality of Hall effect sensors. A method for determining whether an apparatus is removably coupled to a medicament injection device, the apparatus comprising a plurality of sensing elements, a processor in communication with the set of sensing elements;
obtaining a set of voltage measurements from each of the plurality of sensing elements;
determining two-dimensional data representative of a magnetic field of a magnetic component of the medicament injection device;
determining one-dimensional data based on the two-dimensional data;
determining based on the one-dimensional data whether the set of voltage measurements indicates that the apparatus is coupled to the medicament injection device;
How to include. 38. The method of claim 37, wherein determining the two-dimensional data comprises determining an orthogonal signal comprising an in-phase portion and an orthogonal portion. 39. The method of claim 38, wherein determining the one-dimensional data comprises determining a scale factor based on the orthogonal signal. 40. The method of claim 39, wherein determining the scale factor comprises determining the scale factor based on the orthogonal signal and one or more of a predetermined offset and a predetermined gain. 41. The method of any of claims 37-40, wherein the plurality of sensing elements comprises five sensing elements equi-circumferentially and equi-radially spaced within the device. 42. The method of claim 41, wherein the plurality of sensing elements comprises a plurality of Hall effect sensors.

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